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Acetaminophen / dextromethorphan / doxylamine / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / doxylamine / phenylephrine is also known as: Alka-Seltzer Plus Day & Night Cold Formula (Night Cold) Liquid Gels, Alka-Seltzer Plus Multi-Symptom Cold & Flu (Night Formula), Alka-Seltzer Plus Night Cold Formula Liquid, Alka-Seltzer Plus Night Cold Formula Liquid Gels, Alka-Seltzer Plus Severe Sinus Congestion & Cough (Night Formula), Delsym Night Time Multi-Symptom, Tylenol Cold Multi-Symptom Nighttime Liquid, Vicks NyQuil Severe Cold & Flu

Acetaminophen / dextromethorphan / doxylamine / phenylephrine Pregnancy Warnings

Acetaminophen/dextromethorphan/doxylamine/phenylephrine has not been formally assigned to a pregnancy category by the FDA. Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Animal studies have not been reported. There are no controlled data in human pregnancy. Dextromethorphan has been assigned to pregnancy category C by the FDA. A teratogenic effect has been demonstrated in chicken embryos. There are no controlled data in human pregnancy. Doxylamine has been assigned to pregnancy category B by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Phenylephrine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen/dextromethorphan/doxylamine/phenylephrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Acetaminophen / dextromethorphan / doxylamine / phenylephrine Breastfeeding Warnings

There are no data on the excretion of acetaminophen/dextromethorphan/doxylamine/phenylephrine into human milk. Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. There are no data on the excretion of dextromethorphan into human milk. There are no data on the excretion of doxylamine into human milk. However, other antihistamines are excreted into human milk in low concentrations. Small amounts of phenylephrine are secreted in breast milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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